Colbert Tweaks Zicam's Nose
nasal discharge simulator and hygiene station
Last week, the FDA, followed by Health Canada, issued consumer alerts on Zicam’s Cold Remedy nasal gel and swabs because at least 130 users reported suffering loss of the sense of smell, a medical condition called anosmia, after using the product. Despite the seriousness of this health risk to the public, Health Canada does not have the power to order the recall of the product – an authority gap that would have been rectified by Bill C-51. Yet luckily, in this case, the manufacturer Matrixx Initiatives has voluntarily withdrawn the products cited by the FDA.
News of the Zicam alert was picked up quickly by the mainstream media and has been covered by fellow skeptic Dr. Steven Novella at Science-Based Medicine. But nothing undercuts a product’s credibility quite as much as when the late night comedy shows get hold of the story, and on Monday, Stephen Colbert, calling himself a “born skeptic”, took his shots at Zicam and its developer. The video can be seen at The Comedy Network in Canada and at Comedy Central in the US.
“Shocking, disturbing news,” exclaimed Colbert, “which could affect millions …”
“… of dollars for the makers of Zicam.”
Colbert cynically observed:
“I cannot for the life of me understand why the FDA would crack down on an unregulated heavy metal that you spray in your nose that can cause permanent damage.”
About Zicam’s developer, Robert Steven Davidson, Colbert stated that he:
“got his PhD from the American University of Asturias, an unaccredited and now-defunct university in Spain. The American University of Asturias is the Harvard of fake schools. It’s even better than ‘Altered State’ and the ‘Beerniversity of Drinkachusetts’. And just five years later, Davidson got his Bachelor’s degree from the on-line virtual school, Excelsior College. That’s right, he got his PhD first. Getting your BA before your PhD is your dad’s way of doing things, just like researching your medicine’s side-effects before you release it.”
The Washington Post article “The Men Behind Zicam” stated that the health product’s co-developers “have unusual backgrounds” and confirms the backstory of Davidson receiving his doctorate from a “diploma mill”. The other patent holder, Charles Hensley, a professor at the Cleveland Chiropractic College “recently received a warning letter from the [FDA] about the sale over the Internet of an unapproved drug his company makes to treat bird flu” and “previously developed a weight-loss remedy that involves sniffing ‘specially developed aromas’.” Interestingly, the article pointed out that Davidson “declined to discuss whether any safety questions arose during Zicam’s development and testing.”
Even Rush Limbaugh got into the act. Limbaugh’s show is sponsored by Zicam, which implies an affinity between Limbaugh listeners and Zicam users. Colbert played a clip of Limbaugh calling the FDA’s crack down on Zicam “unprecedented”, saying that “the FDA has never done before what it did yesterday,” which is of course nonsense. The FDA releases alerts all the time on products that pose public health risks. Limbaugh claimed that the FDA’s action is a Democrat-inspired plot to get back at him personally, for which Colbert delivered his punchline:
“Now, that may smell like bullshit to some people, but not to users of Zicam.”
Skeptics have been tracking this story for a while. Perhaps the initial legal action concerning anosmia and Zicam was reported by Dr. Stephen Barrett in his 2003 Homeowatch article “Zicam Marketers Sued“. The case’s legal complaint stated that, when Dennis Christensen felt a cold coming on, he used Zicam Cold Remedy Nasal Spray as directed. Afterwards, he “felt an intense stinging and/or burning sensation in his nose”, and subsequent to this single use, he “has totally lost his sense of smell”, a condition which was medically assessed to be “in all likelihood permanent, total and irreversible”.
Other lawsuits followed. In their 2006 article “Is Shelf Life Of Zicam Nasal Spray In Jeopardy?“, LawyersandSettlements.com reported:
“A second lawsuit was filed on December 18, 2003, in Etowah County, Alabama, by Janie Sutherland, and also named Wal-Mart as a defendant. The third lawsuit was filed in Maricopa County, Arizona, in January 2004, by 3 plaintiffs claiming to have lost their sense of smell and taste immediately after using Zicam. After that, lawsuits began sprouting up all over the country.”
To the extent that:
“As of January 18, 2006, according to [Matrixx Initiatives’] filings with the Security and Exchange Commission, there were 49 different lawsuits pending against Matrixx involving approximately 400 individuals.”
Then on 20 January 2006, according to the Washington Post article “Paying Through the Nose“, the company settled out of court with 340 smelling-impaired plaintiffs for $12 million. About.com adds that “the company admitted no wrongdoing or admission that their products caused loss of the sense of smell.”
Denial of corporate liability is not unusual for this type of lawsuit and tracks with the company’s current PR strategy. On the Zicam website, William Hemelt, the president of Matrixx Initiatives, gives his video assurance that their products are safe, but since they want to work with the FDA, the company voluntarily withdrew the products cited in the health alert. Apparently, the problem is not that the products cause adverse reactions but that some consumers reported adverse reactions after using them. He also reassures us that “there is no credible evidence that Zicam Cold Remedy Nasal Gel or Zicam Cold Remedy Gel Swabs causes you to lose your sense of smell,” despite the fact that the company has received 800 consumer complaints about the products.
As skeptics, we accept that these reports are only anecdotal, but the number of reports should have spurred further analysis. If only the FDA had known about them, an investigation could have been initiated. So why did the company not report them to the FDA? Well, Matrixx Initiatives states:
“During the May 2009 audit, the FDA suggested – for the first time – that the FDA’s interpretation of new regulations required the Company to report to the FDA all complaints of diminishment of smell, rather than having those complaints available for FDA inspection. The FDA’s position is directly contrary to the written advice received from the Company’s FDA counsel shortly after the new regulations were adopted.”
Apparently, this whole misunderstanding could have been cleared up if the FDA and the company’s lawyers had been on the ball. Perhaps the company is the innocent victim here, and certainly the product’s many true believers have tweeted their stalwart support. Equally unfortunate is that the company did not, apparently, understand its responsibility under the 2007 FDA regulations for the reporting of adverse reactions to these types of products, despite guidance on the FDA webpage that:
“An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported when the patient outcome is:
Disability. Report if the adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient’s body function/structure, physical activities or quality of life.”
Yet, homeopathic products are typically diluted to the point that not even a molecule of active ingredient is left in solution. How is it possible that a homeopathic product has any physiological effect at all, let alone a negative one. The reason is that not all homeopathic products are diluted to the point of absurdity, and one of those “underdiluted” products is Zicam. Skeptico, for his 2005 article “If it has any ingredient in it, is it homeopathic?“, received the following e-mail explanation from Matrixx Initiatives:
“Zicam has only one active ingredient – zinc gluconate (Zincum Gluconicum). It is true that some homeopathic dilutions are very dilute. The [Homeopathic Pharmacopoeia of the United States (HPUS)] dictates the maximum strength a compound can be for OTC use. In the case of zinc gluconate, it is a 1X dilution. This means that 1 part of zinc gluconate is diluted with 9 parts water. In Zicam we use a 2X dilution. This takes the above dilution and further dilutes it by adding 1 part of it to 9 parts water. This produces a final 1:100 dilution.”
I would have thought that, by homeopathy’s bizarro logic, a 2X dilution would be so “weak” that it’s hardly worth producing. Yet in both Canada and the US, a natural health product is deemed to be homeopathic, not by how diluted it is, but by whether it is listed in an approved homeopathic pharmacopoeia, as circular as that definition seems to be. As a result, Dr. Novella points out, Zicam ends up having enough residual active ingredient to have effects:
“Efficacy of zinc against common cold viruses: an overview.” Journal of the American Pharmacists Association. 2004 Sep-Oct;44(5):594-603.
as well as consequences:
“Anosmia after intranasal zinc gluconate use.” American Journal of Rhinology. 2004 May-Jun;18(3):137-41.
“Intranasal zinc and anosmia: the zinc-induced anosmia syndrome.” The Laryngoscope. 2006 Feb;116(2):217-20.
Having to actually deal with an active ingredient has put a homeopathic manufacturer in an unusual position. But not to worry, we are reassured by the American Association of Homeopathic Pharmacists that homeopathic medications are safe despite the FDA’s concern for this “specific zinc product”, which sounds like they are distancing themselves from an offending mainstream product, and that “[h]omeopathic medications are regulated by the FDA”, which is a meaningless statement since homeopathic products are not regulated for safety or efficacy.
The Zicam situation inspired AP to write the article “Zicam not alone in side effect reports“, which questions the lack of federal regulatory oversight for homeopathic products and featured some wry comments on homeopathy’s origin, such as:
“Homeopathy sprang from the inventive – some would say fanciful – mind of German physician and chemist Samuel Hahnemann”
and
“with arcane ingredients like ‘nux vomica’ and ‘arsenicum album,’ many homeopathic medicines sound like something brewed in a druid’s kettle.”
The article reports what, in a rational world, should summarize the fate of homeopathy:
“The National Institutes of Health’s alternative medicine center spent $3.8 million on homeopathic research from 2002 to 2007 but is now abandoning studies on homeopathic drugs. ‘The evidence is not there at this point,’ says the center’s director, Dr. Josephine Briggs.”
Too bad she felt the need to qualify her statement with “at this point”. I’m certainly not going to hold my breath for supporting evidence to be found.
Nevertheless, the statement hints at the pointlessness of homeopathy, a sentiment further bolstered by this Zicam incident. Typical homeopathic products, which have no active ingredients, are ineffective, while faux homeopathic products like Zicam, which contain active ingredients, need to be studied and regulated outside the superstitious framework of homeopathy as mainstream health products using real science. Coddling homeopathy and sheltering it from strict regulation invites people to waste money and puts their health at risk.
25. June 2009 by barry
Categories: Alt. Med, Topics | Comments Off
